MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON SMALL PART KIT; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751526

Device Problems Break (1069); Material Discolored (1170); Infusion or Flow Problem (2964); Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported several customers indicated two sleeves were not the same as they had different shades of color, the lighter ones were thinner, broke more easily when they were being placed in the phacoemulsification(phaco) needles, get curled especially when trying to enter the incision, and there was a significant reduction in infusion into the eyes.There was no patient harms reported.

Event Description

This is one of multiple reports for these reported events.

Manufacturer Narrative

The manufacturer internal reference number is:(b)(4).

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample was returned for investigation, however, the photo was reviewed on the infusion sleeves.Visual inspection of the photo confirmed a color difference between the sleeves, however the sleeves appeared to fall within the allowable criteria for the specified color range.The sleeve color lot is evaluated for variance by the supplier prior to shipment and when it arrives at the production facility.The color variation does not impact the intended functional of the sleeve.No sample was returned for evaluation, therefore, the condition of the product could not be verified with respect to infusion functionality.The root cause of the customer's complaint could not be established since there was no sample returned and the photo appeared to meet specifications.After the investigation of this complaint, it has been determined no action will be taken for this occurrence as the physical samples could not be evaluated.The supplier was notified of this complaint issue and has reviewed their process to ensure greater consistency in sleeve coloration.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The returned sample was received for investigation.Visual inspection confirmed a color difference between the sleeves.Pantone color comparison confirmed that one of the infusion sleeves did not fall within the allowable criteria for the specified color range.The variation in coloration does not affect the intended function of the sleeve.Inspection found no physical evidence of breakage or irregularity that would impact fit, form, or function.The root cause of the customer¿s complaint is an error that occurred during the supplier¿s manufacturing process.Action was taken to determine root cause and document supplier corrective actions.The supplier has been notified of the complaint issue and has optimized their process to ensure color criteria of all sleeves are met.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• Brand Name: SMALL PART KIT
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12657721
• MDR Text Key: 277183216
• Report Number: 1644019-2021-00646
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657505173
• UDI-Public: 00380657505173
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751526
• Device Lot Number: 2475276H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION SURGICAL PROCEDURE PAK; CENTURION SURGICAL PROCEDURE PAK; CENTURION SURGICAL PROCEDURE PAK; CUSTOM-PAK SURGICAL PROCEDURE PACK; CENTURION SURGICAL PROCEDURE PAK; CENTURION SURGICAL PROCEDURE PAK